Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

NCT ID: NCT00665925

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 457 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

R788, 100 mg tablet, orally, twice-a-day

Group Type: EXPERIMENTAL

Fostamatinib disodium (R935788)

Intervention Type: DRUG

100 mg tablet, orally, twice-a-day

2

R788, 150 mg tablet, orally, once a day

Group Type: EXPERIMENTAL

Fostamatinib disodium (R935788)

Intervention Type: DRUG

150 mg tablet, orally, once a day

3

Placebo, orally, either once a day, or twice a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, orally, either once a day, or twice a day

Interventions

Fostamatinib disodium (R935788)

100 mg tablet, orally, twice-a-day

Intervention Type: DRUG

Fostamatinib disodium (R935788)

150 mg tablet, orally, once a day

Intervention Type: DRUG

Placebo

Placebo, orally, either once a day, or twice a day

Intervention Type: DRUG

Other Intervention Names

R935788; R935788

Eligibility Criteria

Inclusion Criteria

• Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
• Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing.
• Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing.

'Patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.

• Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.

Exclusion Criteria

• In the Investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.

• The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:

1. uncontrolled or poorly controlled hypertension;

2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);

3. recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;

4. recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;

5. Hepatitis B ;

6. Hepatitis C ;

7. interstitial pneumonitis or active pulmonary infection on chest x-ray;

8. Tuberculosis (TB): the TB skin test should be negative.

9. known laboratory abnormalities.

• The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
• The patient has been treated previously treated with R788 under a different protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigel Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel B Magilavy, MD

Role: STUDY_DIRECTOR

Rigel Pharmaceuticals

Locations

Divison of Rheumatology Allergy and Immunology

La Jolla, California, United States

Desert Medical Advances

Palm Desert, California, United States

Arthritis & Osteoporosis Center, PC

Hamden, Connecticut, United States

Cynthia Morgan

Washington D.C., District of Columbia, United States

Florida Medical Research Institute

Gainsville, Florida, United States

Paddock Park Clinical Research

Ocala, Florida, United States

Jeffrey Poiley, MD

Orlando, Florida, United States

Lovelace Scientific Resources

Sarasota, Florida, United States

Rheumatology Associates, SC

Chicago, Illinois, United States

Memorial Medical Group Clinical Research Inst

South Bend, Indiana, United States

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, United States

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, United States

Fiechtner Research, Inc.

Lansing, Michigan, United States

Westroads Medical Group

Omaha, Nebraska, United States

North Carolina Arthritis & Allergy Care Center

Raleigh, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Rheumatology Associates

Erie, Pennsylvania, United States

Clinical Research Center of Reading, LLP

West Reading, Pennsylvania, United States

Rheumatic Disease Associates

Willow Grove, Pennsylvania, United States

Rheumatology Associates

Charleston, South Carolina, United States

Austin Rheumatology & Research

Austin, Texas, United States

Arthritis Center of South Texas

San Antonio, Texas, United States

Arthritis Northwest, PLLC

Spokane, Washington, United States

MNTranspH "Tsar Boris Treti"

Sofia, Gsof, Bulgaria

MHAT "Kaspela"

Plovdiv, PLO, Bulgaria

MHAT Ruse

Rousse, , Bulgaria

DCC "Sv. Anna" Sofia

Sofia, , Bulgaria

Unidad Medica Torre Plaza

Medellín, Antioquia, Colombia

Centro de Reumatologia y Ortopedia

Barranquilla, Atlántico, Colombia

Reumatologos del Caribe

Barranquilla, Atlántico, Colombia

CIREEM

Bogota, Cundinamarca, Colombia

Fundación Instituto de Reumatología

Bogota, Cundinamarca, Colombia

Riesgo de Fractura S.A

Bogota, Cundinamarca, Colombia

Private Office

Bogotá, Cundinamarca, Colombia

Centro Medico Carlos Ardila Lulle

Bucaramanga, Santander Department, Colombia

SERVIMED

Bucaramanga, Santander Department, Colombia

Christus Muguerza del Parque

Chihuahua City, Chihuahua, Mexico

Arké Estudios Clínicos S.A de C.V

México, D.f., Mexico

Clínica para el Diagnostico y Tratamiento de

México, D.f., Mexico

Hospital Ángeles Metropolitano

México, D.f., Mexico

Hospital General de México

México, D.f., Mexico

Hospital Aranda de la Parra

León, Guanajuato, Mexico

Instituto Jalisciense de Investigación Clínica

Guadalajara, Jalisco, Mexico

Hospital Civil de Guadalajara "Fray Antonio A

Guadalajara, Jalisco, Mexico

Centro Médico DALINDE

Mexico City, Mexico City, Mexico

Centro de Investigacion Clinical de Morelia

Morelia, Michoacán, Mexico

Hospital Inovamed , Torre Médica

Cuernavaca, Morelos, Mexico

NZOZ Centrum Medyczne Artur Racewicz

Bialystok, , Poland

Szpit. Spec.Nr 1, Odz. Reumatol. i Reh.

Bytom, , Poland

Wojewodzki Szpital Zespolony Oddzial Reumatol

Elblag, , Poland

Mazowieckie Centrum Badan Klinicznych

Grodzisk Mazowiecki, , Poland

Malopolskie Centrum Medyczne SC

Krakow, , Poland

Krakowskie Centrum Medyczne NZOZ

Krakow, , Poland

NZOZ Reumed

Lublin, , Poland

NZOZ "Nasz Lekarz"

Torun, , Poland

Synexus SCM

Wroclaw, , Poland

ASK Klinika Reumatologii i Chor. Wewn.

Wroclaw, , Poland

ZOZ w Zyradowie Oddzial Reumatologii

Zyradow, , Poland

Spitalul Clinic Judetean de Urgenta Cluj Reum

Cluj-Napoca, Cluj, Romania

Spitalul Clinic "Sf. Maria" Med Int si Reumat

Bucharest, Sector 1, Romania

Spitalul Clinic Judetean Sibiu

Sibiu, Sibiu County, Romania

CMI "Cristei R. Dorica"

Brăila, , Romania

Spitalul de Urgenta al MAI Dr. D. Gerota

Bucharest, , Romania

Spitalul Judetean "Dr. Fogolyan Kristol"

Sf. Gheorghe, , Romania

Countries

United States; Bulgaria; Colombia; Mexico; Poland; Romania

References

Weinblatt ME, Kavanaugh A, Genovese MC, Musser TK, Grossbard EB, Magilavy DB. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. N Engl J Med. 2010 Sep 30;363(14):1303-12. doi: 10.1056/NEJMoa1000500. Epub 2010 Sep 22.

Reference Type: DERIVED

PMID: 20879879 (View on PubMed)

Other Identifiers

C-935788-010

Identifier Type: -

Identifier Source: org_study_id